Validation of the Children's International Mucositis Evaluation Scale (ChIMES)

儿童国际粘膜炎评估量表 (ChIMES) 的验证

• 批准号: 7978578
• 负责人: Lillian Sung
• 金额: $ 5.32万
• 依托单位: HOSPITAL FOR SICK CHLDRN (TORONTO)
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7978578
• 关键词: 12 year old; 18 year old; Adverse effects; Applications Grants; Canada; Caregivers; Child; Childhood; Common Terminology Criteria for Adverse Events; Distress; Enrollment; Evaluation; Facial Pain; Factor Analysis; International; Intervention; Malignant Neoplasms; Measures; Methods; Mouth Sore; Mucositis; National Cancer Institute; Outcome Measure; Pain; Parents; Patient Self-Report; Patients; Prevention; Property; Prospective Studies; Psychometrics; Quality of life; Reporting; Research; Respondent; Stem cell transplant; Testing; Time; United Kingdom; United States; Validation; Validity and Reliability; Visual; World Health Organization; analog; base; cancer stem cell; chemotherapy; clinical care; conditioning; design; high risk; improved; instrument; meetings; oral mucositis; prevent; programs; public health relevance; sound; treatment strategy

DESCRIPTION (provided by applicant): Validation of the Children's International Mucositis Evaluation Scale (ChIMES) Sung, Lillian Preamble: Oral mucositis is one of the most distressing side effects of treatment for children with cancer receiving chemotherapy and stem cell transplantation (SCT). In order to determine the most effective prevention and treatment strategies, we need feasible, psychometrically sound and clinically useful outcome measures of oral mucositis. Our group has developed a program of research in developing a pediatric specific oral mucositis measure and in this grant proposal, we plan to extend our previous research by evaluating the psychometric properties of the Children's International Mucositis Evaluation Scale (ChIMES). Specific Aims: Aim 1 a) To evaluate test-retest reliability by demonstrating an intraclass correlation coefficient (ICC) e 0.7 when the total ChIMES scores are examined on days 13 and 14 for those who report no change in mucositis; b) To evaluate inter-rater reliability by demonstrating an ICC e 0.5 when the total ChIMES scores are compared between parents and children e 12 years of age on day 14; and c) To evaluate internal consistency by expecting Cronbach's alpha e 0.7. Aim 2 a) To evaluate discriminant validity by anticipating total ChIMES scores will be higher with SCT compared to chemotherapy; b) To evaluate convergent validity by anticipating total ChIMES score will be moderately correlated with other measures of mucositis namely visual analogue scale (VAS), National Cancer Institute Common Toxicity Criteria (NCI-CTC), World Health Organization scale (WHO) and Oral Mucositis Daily Question (OMDQ) by anticipating a Spearman correlation e 0.35; and c) To evaluate responsiveness by demonstrating a significant increase in total ChIMES score from baseline to day 14 in children who report oral mucositis on day 14. Methods: This is a multi-center prospective study that will enroll patients in 5 centers in the United States, Canada and the United Kingdom. We will include children 0 to 18 years of age receiving chemotherapy associated with a higher risk of mucositis and those receiving any SCT. We will measure mucositis using ChIMES at baseline and daily from days 7 to 17 following initiation of chemotherapy or conditioning for SCT. Other measures of mucositis will be VAS, NCI-CTC, WHO and OMDQ. For older children (12 years and older), the children will be the respondent while for younger children (less than 12 years), the parent will be the respondent. We intend to enroll 200 subjects over 2 years, which will be sufficient to meet the study aims. Significance: Oral mucositis is one of the most debilitating side effects of chemotherapy. In order to assess whether interventions have a meaningful impact and to facilitate clinical care, feasible, psychometrically sound and clinically useful outcome measures are required. This program of research, to develop such an outcome measure for oral mucositis, is critically important to improve quality of life during treatment for children with cancer who receive chemotherapy and SCT. PUBLIC HEALTH RELEVANCE: Validation of the Children's International Mucositis Evaluation Scale (ChIMES) Sung, Lillian Mouth sores are one of the most distressing and painful side effects of chemotherapy and stem cell transplantation. In order to study treatments to prevent or treat them, we need good instruments to measure mucositis suitable for children and thus, we have developed the Children's International Mucositis Evaluation Scale (ChIMES). This grant proposal is designed to determine whether this instrument is good at measuring the effects of mucositis and thus, our study is critically important in order to study ways to reduce or prevent mouth sores and improve quality of life for children with cancer.

描述（由申请人提供）：儿童国际粘膜炎评估量表（ChIMES）的验证Sung，Lillian前言：口腔粘膜炎是接受化疗和干细胞移植（SCT）的癌症儿童治疗中最令人痛苦的副作用之一。为了确定最有效的预防和治疗策略，我们需要可行的，心理测量的声音和临床有用的口腔粘膜炎的结果措施。我们的小组已经开发了一个研究计划，在开发一个儿科特定的口腔粘膜炎措施，并在此拨款建议，我们计划通过评估儿童的国际粘膜炎评估量表（ChIMES）的心理测量特性来扩展我们以前的研究。具体目标：目的1a）当在第13天和第14天检查那些报告粘膜炎没有变化的儿童的总ChIMES评分时，通过证明组内相关系数（ICC）e0.7来评估重测信度; B）当在第14天比较父母和12岁以下儿童的总ChIMES评分时，通过证明ICC e0.5来评估评分者间信度; c）通过期望Cronbach α e = 0.7来评价内部一致性。目的2a）通过预测SCT的总ChIMES评分高于化疗来评估判别效度; B）通过预期总ChIMES评分将与粘膜炎的其他测量中度相关，即视觉模拟量表（VAS）、国家癌症研究所常见毒性标准（NCI-CTC），世界卫生组织量表（WHO）与口腔粘膜炎日常问卷（OMDQ）的相关系数为斯皮尔曼（Spearman）0.35;以及c）通过证明在报告口腔粘膜炎的儿童中，从基线到第14天，ChIMES总分显著增加，评价反应性。第14天方法：这是一项多中心前瞻性研究，将在美国、加拿大和英国的5个中心招募患者。我们将纳入0至18岁的儿童接受化疗与粘膜炎的高风险和那些接受任何SCT。我们将在基线和开始SCT化疗或预处理后第7 - 17天每天使用ChIMES测量粘膜炎。粘膜炎的其他指标为VAS、NCI-CTC、WHO和OMDQ。对于年龄较大的儿童（12岁及以上），儿童将是答辩人，而对于年龄较小的儿童（12岁以下），父母将是答辩人。我们计划在2年内入组200例受试者，这将足以满足研究目标。意义：口腔粘膜炎是化疗最令人衰弱的副作用之一。为了评估干预措施是否具有有意义的影响，并促进临床护理，需要可行的，心理测量健全和临床有用的结果措施。这项研究计划旨在开发口腔粘膜炎的结局指标，对于改善接受化疗和SCT的癌症儿童治疗期间的生活质量至关重要。 公共卫生关系：儿童国际粘膜炎评估量表（ChIMES）的验证Sung，Lillian口腔溃疡是化疗和干细胞移植最令人痛苦和痛苦的副作用之一。为了研究预防或治疗它们的治疗方法，我们需要良好的仪器来测量适合儿童的粘膜炎，因此，我们开发了儿童国际粘膜炎评估量表（ChIMES）。这项拨款提案旨在确定该仪器是否擅长测量粘膜炎的影响，因此，我们的研究对于研究减少或预防口腔溃疡和提高癌症儿童生活质量的方法至关重要。